A wide variety of airway management devices exist. Airway management devices may be used for a variety of reasons including the facilitation of speaking and breathing following a laryngectomy, the promotion of healing in the patient, the provision of an access point for forced ventilation of a patient, and a variety of other uses including supplying oxygen to augment normal breathing. In particular, attention is directed to tracheostomy tubes and devices used in conjunction with airways, for example, stoma stents, tracheal T-tubes, transtracheal oxygen stents, bronchial stents, and nasal splints, among others.
Tracheostomy tubes are used to administer positive-pressure ventilation, to protect against aspiration, to provide an airway in patients prone to upper airway obstruction, and to provide access to the lower respiratory tract for airway clearance. Tracheostomy devices may be designed to be used with an inner cannula. The inner cannula is inserted into the tube or outer cannula, and is used to maintain the airway provided by the outer cannula as clean. The inner cannula may be disposable or may be reusable such that it is cleaned or replaced periodically with a new inner cannula. The inner cannula can be a low-profile inner cannula which is used for spontaneous breathing, or an inner cannula with a connector to attach a ventilator.
Stoma stents are prostheses that are held in place in the stoma following a tracheostomy to help maintain patency of the tracheostomy. Bronchial stents are prostheses that relieve an area of obstruction in the airways that lead to each lung.
Those of skill in the art will appreciate that the management of bodily airways is not limited to those devices enabling respiration, but rather may extend to the panoply of devices relating to diseases of the larynx, pharynx, or nasal passages.
A laryngectomy is one procedure that implicates airway management devices. A patient may undergo a laryngectomy in response to cancer of the larynx or possibly because of trauma to the region. A total laryngectomy will have profound effects on the patient. In a total laryngectomy, the larynx is surgically separated from the mouth, nose and esophagus, and the entire larynx, including the vocal chords, is removed. The patient must thereafter use a laryngectomy tube for breathing. Further, due to the separation and lack of vocal chords, a patient may initially be unable to speak.
Some airway management devices are non-respiratory in the sense that they do not enable breathing directly, but still are related to the respiratory system generally. In healthy individuals, the larynx is instrumental for speech, but for laryngectomicized individuals speech is still possible through alternative methods using speech prosthetic devices. Voice button devices, such as a “Panje” voice button and a “Groningen” voice button, help restore speech by allowing air, but not fluids, through an artificial fistula formed between the larynx and the esophagus.
Other non-respiratory airway management devices include salivary bypass tubes and esophageal tubes. Laryngectomies may create salivary fistulas which are problematic if formed over the laryngectomy stoma. This detrimental post-laryngectomy effect can be treated by using a salivary bypass tube. Also, following a laryngoesophagectomy, an esophageal tube may be used to bridge the gap between the pharyngostome and esophagostome.
Another example of a condition that may necessitate an airway management device is laryngeal stenosis. Laryngeal stenosis may occur if a patient has been intubated for a prolonged period of time. One device used in its treatment is a laryngeal umbrella keel. Laryngeal umbrella keels are sometimes used before removing a laryngeal stent, to insure reformation of a sharp anterior commissure and to prevent formation of an anterior web.
Nasal splints are often used to relieve obstructions in the nasal cavity. Obstructions may occur, for example, following surgery of the nasal cavity and paranasal sinuses, which often results in the mucosal lining the nasal cavity becoming raw and rough and to form scars. They are inserted after nasal surgery on turbinates, the polyps (polypectomy), the septum (septoplasty), and after sinus surgery. The splints offer an airway (if the design incorporates a lumen, or tube); reduce, prevent or treat, the occurrence of synechiae formation (granulation); prevent adhesions of tissues or membranes within the nasal cavity; and control bleeding.
However, all of these devices suffer from several drawbacks. Airway management devices are often plagued by granulation, crusting and mucus build up. Further, such devices run the risk of compromising bodily walls and can be difficult for the patient to clean and maintain. In addition, ease of insertion and removal of complementary devices such as tubes can be hampered by the build up or encrustation of bodily fluids or by device fit friction. At the same time, however, another problem with airway management devices is the possibility of becoming accidentally dislodged. Thus there is a need for airway management devices which prevent build up of mucus, encrustation, or bodily fluids, yet remain firmly implanted in the patient with little likelihood of becoming accidentally dislodged. The present invention is directed towards a device solving these and other problems associated with the known devices.